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Data / Medical devices / Shunt, Central Nervous System And Components / United States

FDA-registered makers of Shunt, Central Nervous System And Components in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Shunt, Central Nervous System And Components (product code JXG). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Shunt, Central Nervous System And Components
Product code
JXG
Country
United States

Makers of Shunt, Central Nervous System And Components in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer39March 10, 2025092api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer32June 23, 2026000api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer22October 11, 2019010api.fda.gov
Natus Medical IncorporatedSan Diego, CA, United StatesComplaint file establishment, Specification developer20October 28, 2016020api.fda.gov
Anuncia Medical, Inc.Scottsdale, AZ, United StatesComplaint file establishment, Specification developer2December 29, 2022000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer2October 19, 2023000api.fda.gov
Phasor Health, LLCHouston, TX, United StatesComplaint file establishment, Manufacturer2November 5, 2025000api.fda.gov
Borvo Medical, Inc.Mountain View, CA, United StatesComplaint file establishment, Specification developer1August 20, 2024000api.fda.gov
BRAINSPACE IncBothell, WA, United StatesManufacturer1December 10, 2025000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Classic Industries, Inc.Latrobe, PA, United StatesContract manufacturer0000api.fda.gov
Fmi LLCLincolnshire, IL, United StatesContract manufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Medeologix LLCSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
PMC SMART Solutions, LLCShelbyville, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remedy Medical ManufacturingMesa, AZ, United StatesContract manufacturer0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Tegra Medical - Dartmouth, MADartmouth, MA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.